BAY1003803 Single and Multiple Dose Escalation, Safety, Tolerability and Pharmacokinetics Study

Overview

Systemic safety following single and multiple dermal administration of BAY1003803

Full Title of Study: “Escalating Dose Study for Safety, Tolerability and Pharmacokinetics After Single and Multiple Dermal Administration of Two BAY1003803 Formulation Types With Two Concentrations Each in Healthy Male Volunteers, Applying a Double-blind, Vehicle-controlled Design and Including a Positive Control Group”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 18, 2017

Interventions

  • Drug: BAY1003803 0.01% lipophilic cream
    • Topical administration for 22 h per day
  • Drug: BAY1003803 0.1% lipophilic cream
    • Topical administration for 22 h per day
  • Drug: BAY1003803 0.01% ointment
    • Topical administration for 22 h per day
  • Drug: BAY1003803 0.1% ointment
    • Topical administration for 22 h per day
  • Drug: Lipophilic cream vehicle
    • Topical administration for 22 h per day
  • Drug: Ointment vehicle
    • Topical administration for 22 h per day
  • Drug: Clobetasol propionate
    • Topical administration for 22 h per day

Arms, Groups and Cohorts

  • Experimental: BAY1003803
    • Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject
  • Placebo Comparator: Placebo
    • Topical treatment using matching amount of placebo
  • Active Comparator: Clobetasol propionate
    • Topical treatment using 16.5 mg of clobetasol propionate per subject

Clinical Trial Outcome Measures

Primary Measures

  • Cortisol serum levels for safety
    • Time Frame: Up to 2 weeks
  • Frequency of treatment-emergent adverse events (TEAEs)
    • Time Frame: Up to 2 weeks
  • Nature of treatment-emergent adverse events (TEAEs)
    • Time Frame: Up to 2 weeks

Secondary Measures

  • Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 1, single dose)
    • Time Frame: Day 1 to 3 at 8:00 am
  • Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 2, multiple dose)
    • Time Frame: Day 1 to 8 at 8:00 am
  • Maximum plasma concentration (Cmax) after single dose of BAY1003803
    • Time Frame: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24 hours
  • Area under the plasma concentration vs. time curve from zero to infinity (AUC) after single dose of BAY1003803
    • Time Frame: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24, 27, 31, 35, 39, 47 hours
  • Area under the curve from time zero to 22 hours [AUC(0-22)] after single dose of BAY1003803
    • Time Frame: At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22 hours
  • Maximum plasma concentration (Cmax,md) after multiple dose of BAY1003803
    • Time Frame: At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6)
  • Area under the curve from time zero to 24 hours [AUC(0-24)md] after multiple dose of BAY1003803
    • Time Frame: At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6)

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy male subject – Age: 18 to 64 years (inclusive) at the first screening visit – Body mass index (BMI): above or equal 18 and below or equal 30 kg / m² at the first screening visit – Non-smoker at least 3 months prior to study start and during the study – Healthy skin on which reddening can be easily recognized Exclusion Criteria:

  • A history of relevant diseases, especially incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, excretion and effect of the study drugs will not be normal, dermal diseases, diseases which present a risk for subjects to be treated with glucocorticoid receptor agonists (e.g. gastric ulcers, cornea ulcer, colitis ulcerosa, severe infections, glaucoma, diabetes, myocardial infarction, thromboembolic disease, hypertension, thyroid disease, tuberculosis, myasthenia gravis, osteoporosis, psychiatric diseases) – Infections and febrile illness within 4 week before the first study drug administration – Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them – Inoculations with live vaccine within 8 weeks before the first study drug administration – Signs of irritation or folliculitis or any other dermatological conditions in the test areas that would interfere with the planned assessments as judged by the Investigators – Human leukocyte antigen-DR (HLA-DR) < 15000 AB/monocyte

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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